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Completed

NCT Number: NCT00447304

Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy

Acute cholecystitis is frequent in the elderly, or in patients with gall stones. Most cases of severe or recurrent cholecystitis need surgery as final therapy. Today, the performed procedure in most cases for cholecystectomy in the western world is laparoscopic cholecystectomy. Only in some cases an open surgery has to be performed. Unclear is, what time point is best, concerning outcome and morbidity of the patient, immediate surgery or initial conservative therapy using antibiotics and symptomatic therapy with cholecystectomy later on. Today the performed procedure is mainly chosen by the fact, what doctor sees the patient first, surgeon or gastroenterologist. This study is performed to evaluate if one therapy is superior.

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Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases Infections Intraabdominal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Heidelberg

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of age > 18 years
  • Patients with acute cholecystitis based on three of the following signs
  • abdominal pain in the upper right quadrant
  • Murphy's sign
  • leucocytosis > 10 /ml
  • rectal temperature > 38 °C or < 36.5 °C plus
  • cholecystolithiasis (stones / sludge) or sonographic signs of cholecystitis (thickening and triple layer formation of the gall bladder wall)
  • Immediate antibiotic therapy (400 mg Moxifloxacin i.v. once a day)
  • Laparoscopic cholecystectomy possible within 24 hours after presentation of the patient
  • Informed consent

Exclusion criteria

  • ASA IV and V (table 2)
  • Septic shock
  • Perforation or abscess of the gall bladder
  • Impossibility of laparoscopic surgery (further surgery, surgeon, …)
  • Additional need of antibiotics due to secondary disease
  • Known intolerability of Moxifloxacin
  • Known or possible pregnancy, breast feeding
  • Life-threatening diseases (life-expectancy < 48 hours)
  • End-stage liver disease (Child-Pugh C)
  • Psychiatric or severe neurologic disease
  • Relevant bradycardia or other symptomatic arrhythmias
  • Significant cardiac disease
  • Known long QT-disorders
  • Electrolyte disorders, especially hypocalcemia
  • Known intolerability of chinolones
  • Earlier participation in this trial

Treatment and study plan

moxifloxacin

Drug

Cholecystectomy

Procedure

Primary outcomes

  1. morbidity at the test-of-cure visit

Secondary outcomes

  1. Morbidity over 75 days using the score system showed in table 1

  2. Morbidity 3 days after cholecystectomy (early or elective)

  3. Necessity rate of conversion from laparoscopic to open surgery

  4. Change of antibiotic due to non-response or non-toleration of moxifloxacin

  5. Mortality at day 75

  6. Cost-efficiency (comparing both trial branches)

  7. Hospital time

  8. Safety and tolerability of Moxifloxacin

  9. In-hospital time after cholecystectomy (days)

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • Bayer

Registry information

Official study title

Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-study

Acronym: ACDC

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Mar 14, 2007
Registry last updated
Jul 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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